Cholangiography/Cholangioscopy/Lihopaxy System
FDA 510(k) K913986 · Medical Dynamics, Inc.
510(k) numberK913986
Submission
- Device name
- Cholangiography/Cholangioscopy/Lihopaxy System
- Applicant
- Medical Dynamics, Inc.
Englewood, CO, US - Received
- September 5, 1991
- Decision date
- January 28, 1992
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FGE – Stents, Drains And Dilators For The Biliary Ducts
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5010
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
- Life-sustaining
- Yes
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| K260835 | ARCHIMEDES Biodegradable Stent (Medium)FGE · Traditional | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) | 07/27/2026SE |
| K253393 | Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018…FGE · Traditional | Hangzhou AGS MedTech Co., Ltd. | 06/24/2026SE |
| K253832 | Dilation Balloon CatheterFGE · Traditional | Mirco-Tech (Nanjing) Co., Ltd. | 04/24/2026SE |
| K251658 | Endoflux Biliary & Pancreatic Stent SetsFGE · Traditional | Medi-Globe GmbH | 04/16/2026SE |
| K253987 | BARE Wireguided Balloon Dilation Catheter (1235)FGE · Traditional | GIE Medical | 03/13/2026SE |
| K253132 | Single use stone retrieval balloonsFGE · Traditional | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 03/06/2026SE |
| K251123 | Niti-S Biliary Stent; Niti-S Biliary Slim M StentFGE · Traditional | Taewoong Medical Co., Ltd. | 12/29/2025SESU |
| K251019 | BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-GFGE · Traditional | Bioteque Corporation | 12/22/2025SE |
| K250409 | Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable…FGE · Traditional | Olympus Medical Systems Corporation | 10/21/2025SE |
| K251229 | EndoFixTissue Fixation SystemFGE · Traditional | Softac Medical Technologies | 08/20/2025SE |
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|---|---|---|
| K974542 | True Vision, True Vision IIEIA · Traditional | 02/17/1998SE |
| K921294 | Video Endoscope-Rigid ModificationHET · Traditional | 07/20/1994SE |
| K934682 | Surgical Video Camera and AccessoriesFWF · Traditional | 02/15/1994SE |
| K930568 | Adair/Veress Needle Introducer SetGCB · Traditional | 07/22/1993SE |
| K915538 | Over the Wire Stone BasketLQR · Traditional | 03/20/1992SE |
| K914315 | Optical Catheter Introducer Sets, ModificationKGX · Traditional | 03/04/1992SE |
| K911296 | Optical Catheter ArthroscopeHRX · Traditional | 09/24/1991SE |
| K903339 | Video Endoscope, RigidHET · Traditional | 03/06/1991SE |
| K904609 | Xenon Light SourceHBI · Traditional | 12/18/1990SE |
| K904113 | Operative Recording CameraIKO · Traditional | 10/30/1990SE |
Questions and answers
When was Cholangiography/Cholangioscopy/Lihopaxy System cleared by the FDA?
Cholangiography/Cholangioscopy/Lihopaxy System (K913986) received a 510(k) decision of Unknown on January 28, 1992, 145 days after the submission was received.
What is the product code of K913986?
The FDA product code is FGE – Stents, Drains And Dilators For The Biliary Ducts, a Class II (moderate risk) device regulated under 21 CFR 876.5010.